Traumatic brain injury protection devices

ABSTRACT

The disclosure provides neck collar devices and systems for the mitigation and prevention of traumatic brain injury, including concussion. Specifically disclosed are adjustable collars and systems, and collars having certain pressure sensing devices.

CROSS-REFERENCE TO RELATED APPLICATIONS

The subject application is a continuation of PCT Patent Application No.PCT/US16/62335, filed Nov. 16, 2016, which claims priority to U.S.Provisional Patent Application No. 62/256,093, filed on Nov. 16, 2015,both of which are incorporated by reference herein in their entirety forall purposes.

FIELD OF THE INVENTION

The present invention provides neck collar devices and systems for themitigation and prevention of traumatic brain injury, includingconcussion.

BACKGROUND OF THE INVENTION

Traumatic brain injury (TBI) may occur when a person experiences animpact or external force. For example, TBI may arise is sports in whichplayers make physical contact with each other or the ground/playingsurface (e.g., football, ice hockey, etc.) or contact with a ball (e.g.,soccer). TBI also may arise when individuals (military personnel) aresubject to blast or pressure waves, including those caused by explosivedevices. Generally, the injurious force may be applied to the head orelsewhere on the body in a manner that either transfers the force to thehead or causes the head to undergo a rapid rotation, acceleration,and/or deceleration.

Helmets are normally used to protect the head against injury. It hasbeen found that helmets can be very effective for protection againstpenetrating brain injury and skull fractures, but have shown littleeffect in protecting against intracranial injuries such as concussion.It is believed that these intracranial injuries result from therotational and other forces experienced by the brain during a collision,blast wave, and/or rapid acceleration/deceleration.

It has been discovered that increasing the intracranial blood pressureand/or volume can reduce or prevent the incidence of TBI in the absenceof a penetrating brain injury by increasing the coefficient ofrestitution of the brain structure itself. (see, for example, U.S. Pat.Nos. 8,985,120, 9,168,045, 9,173,660 and 8,900,169, and U.S. patentapplication Ser. Nos. 13/489,536 , now U.S. Pat. No. 10,004,515 and14/317,282, now U.S. Pat. No. 10,842,502.) One safe and effective methodfor increasing intracranial blood pressure and/or volume is by thepartial or total occlusion of blood flow through one or more neck veins(e.g., the internal jugular vein(s) and/or the external jugularvein(s)). Thus, there is a need for convenient, wearable devices thatocclude neck vein blood flow and are capable of accurate sizing,positioning, and neck vein pressure delivery.

SUMMARY OF THE INVENTION

The present invention provides modular collars, expandable collars, andsystems and components for constructing modular and expandable collarsthat may be used to reduce the severity of, or prevent the occurrence ofa traumatic brain injury (TBI) (e.g., a concussion) in a subject wearingthe collar. In some embodiments, the TBI is mitigated or prevented whenthe subject experiences an external concussive force (e.g., a collisionor a blast wave) delivered to any part of the body including, forexample, the head. The collar functions by applying pressure to one ormore (e.g., 2, 3, 4, or more) neck veins including, for example, theinternal jugular vein (IJV), external jugular vein (EJV), or both. Neckvein pressure is applied before and during the external concussiveforce.

In one aspect, the invention provides a modular collar sized to be wornaround the neck of a human subject, the collar comprising: (a) a centralmember having a first mating pair member at a first end and a secondmating pair member at a second end; (b) a first side member having acomplimentary first mating pair member at a first end and a firstcompressor at a second end; and (c) a second side member having acomplimentary second mating pair member at a first end and a secondcompressor at a second end. The collar is assembled by mating the firstmating pair member with the complimentary first mating pair member andmating the second mating pair member with the complimentary secondmating pair member such that the assembled collar has a substantiallycircular shape (e.g., circular, oval, or elliptical) defining an arc ofgreater than 180° (e.g., greater than 210°, 240°, 270°, 300°, or 330°,or any intermediate range thereof including, for example between about180° and 300°).

In another aspect, the invention provides a modular collar system forconstructing a collar sized to be worn around the neck of a humansubject, the system comprising: (a) one or more central members having afirst mating pair member at a first end and a second mating pair memberat a second end; (b) one or more first side members having acomplimentary first mating pair member at a first end and a firstcompressor at a second end; and (c) one or more second side membershaving a complimentary second mating pair member at a first end and asecond compressor at a second end. The system is used to assemble one ormore collars, as defined above. Each collar is assembled by selecting acentral member, a first side member, and a second side member such thatthe fully assembled collar has the appropriate size and features desiredby the user. The collar is assembled by mating the first mating pairmember (on the selected first side arm) with the complimentary firstmating pair member (on the selected central member) and mating thesecond mating pair member (on the selected second side arm) with thecomplimentary second mating pair member (on the selected central member)such that the assembled collar has a substantially circular shape (e.g.,circular, oval, or elliptical) defining an arc of greater than 180°(e.g., greater than 210°, 240°, 270°, 300°, or 330°, or any intermediaterange thereof including, for example between about 180° and 300°).Optionally, the system provides two or more (e.g., 2, 3, 4, 5, 6, ormore) central members. Optionally, the system provides, instead or inaddition to multiple central members, two or more (e.g., 2, 3, 4, 5, 6,or more) first side members and second side members. In one embodiment,the first and second side members are provided in matched pairs and,therefore, are present in equal numbers; although this is notnecessarily the case.

In any of the foregoing aspects, the assembled collar generally will besymmetrical (e.g., the first and second side members having the samelength, curvature, and other structural/functional features), butasymmetrical collars may be constructed either through the use ofdifferently-sized side members or an offset central member (i.e., thatis not symmetrical on either side of its central axis). When assembled,the first and second compressors are positioned on the collar such thatthey contact two or more neck veins of the subject when the collar isworn around the neck, and the collar is adapted to exert aninwardly-directed force on the first and second compressors when worn.The mating pair members may form a reversible attachment, apermanent/irreversible attachment, or a slidable attachment (whetherreversible or irreversible) to form a modular and adjustable collar.

In any of the foregoing aspects, first and second compressors may bepermanently affixed to the side members or they may be removable.Optionally, the compressors are slidably engaged with the side membersin a manner that allows for translocation along the body-facing surfaceof the collar. In some embodiments, the compressors are expandable inthe body-facing direction (i.e., expansion increases the thickness ofthe collar body/compressor combination in order to apply more pressureto the neck veins and/or provide a tighter/more secure fit). Optionally,the compressors are inflatable (e.g., contains an inflatable bladder).The inflatable element may be inflated using an integrated pump (e.g., abulb pump) or may be inflated via a connection to an external gassource. Optionally, the inflatable element also contains a pressurerelease valve that may be configured to automatically release theinflation gas when a pre-determined pressure is exceeded and/or may bemanually operated to release the inflation gas.

In any of the foregoing aspects, the central member(s) also contains afit adjustment element attached to the body-facing surface. The fitadjustment element may be permanently affixed to the central member orit may be removable. It may comprise a rigid, semi-rigid, and/orcompressible form, such as a foam pad or hard plastic shape. Optionally,the fit adjustment element is inflatable (e.g., contains an inflatablebladder). The inflatable element may be inflated using an integratedpump (e.g., a bulb pump) or may be inflated via a connection to anexternal gas source. Optionally, the inflatable element also contains apressure release valve that may be configured to automatically releasethe inflation gas when a pre-determined pressure is exceeded and/or maybe manually operated to release the inflation gas.

In another aspect, the invention provides a modular collar system forconstructing a collar sized to be worn around the neck of a humansubject, the system comprising (a) one or more (e.g., 1, 2, 3, 4, 5, 6,or more) central members having a first mating pair member at a firstend and a second mating pair member at a second end; (b) one or more(e.g., 1, 2, 3, 4, 5, 6, or more) first side members having acomplimentary first mating pair member at a first end and a third matingpair member at a second end; (c) one or more (e.g., 1, 2, 3, 4, 5, 6, ormore) second side members having a complimentary second mating pairmember at a first end and a third mating pair member at a second end;(d) one or more (e.g., 1, 2, 3, 4, 5, 6, or more) first compressors andone or more (e.g., 1, 2, 3, 4, 5, 6, or more) second compressors, eachhaving a complimentary third mating pair member on an outward-facingside. The system is used to assemble one or more collars, as definedabove. Each collar is assembled by selecting a central member (if morethan one is provided), a first side member (if more than one isprovided), a second side member (if more than one is provided), a firstcompressor (if more than one is provided), such that the fully assembledcollar has the appropriate size and features desired by the user. Thecollar is assembled by mating the first mating pair member (on theselected first side arm) with the complimentary first mating pair member(on the selected central member) and mating the second mating pairmember (on the selected second side arm) with the complimentary secondmating pair member (on the selected central member) such that theassembled collar has a substantially circular shape (e.g., circular,oval, or elliptical) defining an arc of greater than 180° (e.g., greaterthan 210°, 240°, 270°, 300°, or 330°, or any intermediate range thereofincluding, for example between about 180° and 300°). Each compressors isattached to its respective side member by mating the third mating pairmember on the side member with the corresponding complimentary thirdmating pair member on the compressor. It is understood that the order ofassembly is not important to the overall construction of the device. Insome embodiments, the first and second side members are provided inmatched pairs and, therefore, are present in equal numbers; althoughthis is not necessarily the case.

The assembled collar generally will be symmetrical (e.g., the first andsecond side members having the same length, curvature, and otherstructural/functional features), but asymmetrical collars may beconstructed either through the use of differently-sized side members oran offset central member (i.e., that is not symmetrical on either sideof its central axis). When assembled, the first and second compressorsare positioned on the collar such that they contact two or more neckveins of the subject when the collar is worn around the neck, and thecollar is adapted to exert an inwardly-directed force on the first andsecond compressors when worn. The mating pair members may form areversible attachment, a permanent/irreversible attachment, or aslidable attachment (whether reversible or irreversible) to form amodular and adjustable collar.

In some embodiments, the first and second compressors are provided inmatched pairs and, therefore, are present in equal numbers; althoughthis is not necessarily the case. The mating pair members may form areversible attachment, a permanent/irreversible attachment. Optionally,the compressors are slidably engaged with the side members in a mannerthat allows for translocation along the body-facing surface of thecollar. In some embodiments, the compressors are expandable in thebody-facing direction (i.e., expansion increases the thickness of thecollar body/compressor combination in order to apply more pressure tothe neck veins and/or provide a tighter/more secure fit). Optionally,the compressors are inflatable (e.g., contains an inflatable bladder).The inflatable element may be inflated using an integrated pump (e.g., abulb pump) or may be inflated via a connection to an external gassource. Optionally, the inflatable element also contains a pressurerelease valve that may be configured to automatically release theinflation gas when a pre-determined pressure is exceeded and/or may bemanually operated to release the inflation gas.

In some embodiments, the central member(s) also contains a fitadjustment element attached to the body-facing surface. The fitadjustment element may be permanently affixed to the central member orit may be removable. It may comprise a rigid, semi-rigid, and/orcompressible form, such as a foam pad or hard plastic shape. Optionally,the fit adjustment element is inflatable (e.g., contains an inflatablebladder). The inflatable element may be inflated using an integratedpump (e.g., a bulb pump) or may be inflated via a connection to anexternal gas source. Optionally, the inflatable element also contains apressure release valve that may be configured to automatically releasethe inflation gas when a pre-determined pressure is exceeded and/or maybe manually operated to release the inflation gas.

In another aspect, the invention provides an expandable collar sized tobe worn around the neck of a human subject, the collar comprising: (a) acentral member having a first end and a second end; (b) a first sidemember having a first end slidably engaged with the first end of thecentral member and a second end comprising a first compressor; and (c) asecond side member having a first end slidably engaged with the secondend of the central member and a second end comprising a secondcompressor, wherein the collar defines an arc of greater than 180°(e.g., greater than 210°, 240°, 270°, 300°, or 330°, or any intermediaterange thereof including, for example between about 180° and 300°) havinga diameter D; and wherein diameter D is altered by the slidableengagement of the first side member and central member, and the slidableengagement of the second side member and the central member; and whereinthe collar is adapted to exert an inwardly-directed force on the firstand second compressors when worn.

The compressors may be removable from the side members or permanentlyattached and may be slidably engaged or immobilized, as describedherein. In some embodiments, the compressors are expandable in thebody-facing direction (i.e., expansion increases the thickness of thecollar body/compressor combination in order to apply more pressure tothe neck veins and/or provide a tighter/more secure fit). Optionally,the compressors are inflatable (e.g., contains an inflatable bladder).The inflatable element may be inflated using an integrated pump (e.g., abulb pump) or may be inflated via a connection to an external gassource. Optionally, the inflatable element also contains a pressurerelease valve that may be configured to automatically release theinflation gas when a pre-determined pressure is exceeded and/or may bemanually operated to release the inflation gas. In some embodiments, theinvention provides a system comprising the expandable collar and a twoor more pairs of removable compressors. The compressors are provided inmatched pairs and, therefore, are present in equal numbers; althoughthis is not necessarily the case.

In any of the foregoing aspects, the central member(s) also contains afit adjustment element attached to the body-facing surface. The fitadjustment element may be permanently affixed to the central member orit may be removable. It may comprise a rigid, semi-rigid, and/orcompressible form, such as a foam pad or hard plastic shape. Optionally,the fit adjustment element is inflatable (e.g., contains an inflatablebladder). The inflatable element may be inflated using an integratedpump (e.g., a bulb pump) or may be inflated via a connection to anexternal gas source. Optionally, the inflatable element also contains apressure release valve that may be configured to automatically releasethe inflation gas when a pre-determined pressure is exceeded and/or maybe manually operated to release the inflation gas.

In another aspect, the invention provides a method for reducing orpreventing a TBI, or an injury to the inner ear and/or an ocularstructure caused by exposure to a concussive force by applying a collardevice, as described herein, to the neck of a subject (e.g., a subjectidentified as being at risk of exposure to a concussive force) prior toand during exposure to that concussive force.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a partially-circumferential collar worn around theneck of a subject, wherein the collar is open at the laryngealprominence.

FIG. 2 is a schematic of a unitary collar body illustrating certainfeatures of the collar body and collar device.

FIG. 3 is a plan view of a unitary collar body.

FIG. 4 is a schematic of a modular collar body.

FIG. 5 is a schematic of another modular collar body.

FIG. 6 is a schematic of a connector system that may be used with thevarious elements of a modular collar body.

FIG. 7 is a schematic of another connector system that may be used withthe various elements of a modular collar body.

FIG. 8 is a schematic of a magnetic connector system that may be usedwith the various elements of a modular collar body.

FIG. 9 is a schematic of an expandable collar body.

FIG. 10 is a schematic of connectors that may be used with the variouselements of an expandable collar body.

FIG. 11 is a cross-sectional view through the connector systemillustrated in FIG. 10.

FIG. 12 is another cross-sectional view through the connector systemillustrated in FIG. 10.

FIG. 13 is a schematic of a detents-and-notches size adjustment system.

FIG. 14 is a schematic of a collar body having adjustable compressors.

FIG. 15 is a schematic of a collar body mating system for use withadjustable compressors.

FIG. 16 is a schematic of an adjustable compressor and engagementmechanism.

FIG. 17 is a schematic showing an adjustable compressor engaged with acollar body.

FIG. 18 is a schematic showing another adjustable compressor engagedwith a collar body.

FIG. 19 is a schematic showing an expandable compressor in a compressedstate.

FIG. 20 is a schematic showing an expandable compressor in an expandedstate.

FIG. 21 is a schematic of a unitary collar body with a fit adjustmentelement on the body-facing surface.

FIG. 22 is a schematic showing a collar with a plurality of bend anglesensors.

FIG. 23 is a schematic illustrating the components of one type of bendangle sensor.

FIG. 24 is a schematic of an assembled bend angle sensor.

FIG. 25 is a schematic of a bend angle sensor within a protectivehousing.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides collar devices that are designed to beworn around the neck of the subject and apply pressure one or more(e.g., two, three, four, or more) neck veins including, for example, theinternal jugular veins (IJV) and external jugular veins (EJV). Thecollars are partially circumferential (i.e., extend around only aportion of the subject's neck). In some embodiments, thepartially-circumferential collars are open at the back or at the front(i.e., exposing the laryngeal prominence) and are designed such that thesubject's neck passes through the opening when the collar is donned.Optionally, the front of a back-opened collar (i.e., region thatoverlies the throat and laryngeal prominence) contains a protectiverigid member that is useful to protect the underlying neck structuresfrom slashes (e.g., from hockey skates) or blunt trauma caused bycontact with another piece of sporting equipment (e.g., puck, ball,stick, racquet, etc.). Likewise, front-opened collars may have a similarprotective piece that may be independently affixed after the collar isdonned. For example, the rigid front protective member may be entirelyremovable and attachable using any type of suitable reversible closures,or may be engaged by a hinge on one side and a reversible closure on theother so that the front opening may be open to allow passage of the neckduring donning, followed by closure of the front protective member afterthe collar is in place.

The collars have inwardly-directed compressors which may beprotuberances or thickened regions that contact the neck in regionoverlying the neck veins such that pressure is applied to those neckveins. The inwardly-directed protuberances may be a non-inflatable rigidor semi-rigid stud or pad made of plastic, foam, metal or any othersuitable material, or an inflatable member such as a pad. The thickenedregions may inflatable or non-inflatable, may be rigid or semi-rigid,and may be formed from any suitable material including plastic, foam, ormetal. Any inflatable element has an inflation device which may be anintegral or operably-linked bulb pump that is integral to the collar, ora port from inflation from an external pressurized gas source.Optionally, any of the inflatable elements is operably linked to apressure release valve that may be configured to automaticallyrelease/vent the inflation gas upon a predetermined pressure.

Optionally, the collars may contain one or more monitoring or recordingdevices including, for example, a pressure sensor and accelerometer.Optionally, the collar device has a wired or wireless communicationinterface operably linked to the sensor(s) and an optional digitalmemory unit configured for storing sensor data. Communication interfacesmay be a radio frequency transmitter (e.g., Bluetooth, WiFi, etc.) or awired interface (e.g., USB port).

The principles and features of the construction and use of the collarsare described herein an in U.S. Pat. Nos. 8,985,120, 9,168,045, and9,173,660, U.S. Patent Publications 2014/0142616 and 2014/0343599, andPCT publications WO 2012/054262 and WO 2013/05409, each of which ishereby incorporated by reference in its entirety.

Collar Design and Construction

FIGS. 1-3 show an example of a collar 10 adapted to be worn on asubject's neck to protect the subject against a traumatic brain injury(TBI), such as a concussion, caused by an impact or other externalforce. The collar 10 is configured to apply pressure on one or more neckveins. The pressure applied to the neck veins may be any pressure thatresults in an increase in the intracranial blood pressure and/orintracranial blood volume. Suitable pressures include, for example,about 5-100 mm Hg, 5-80 mm Hg, 10-80 mm Hg, 20-60 mm Hg, and 30-50 mmHg, or at least about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80mm Hg. Optionally, the collar is configured to limit the maximum neckvein pressure to not more than about 40, 50, 60, 70, 80, 90, or 100 mmHg.

FIG. 1 illustrates collar 10 worn around the subject's neck. Collar 10is partially circumferential and open at the front, specifically open toexpose the laryngeal prominence 15. In this configuration, collar 10 isstretched such that the subject's neck passes through opening 14 (see,FIG. 2) when donned, and the shape memory property of the collar 10reduces the opening 14 size such that collar 10 applies pressure theneck vein(s).

FIG. 2 illustrates the features of collar 10 in more detail. Collar 10comprises body 12 to apply the pressure on the veins of the wearer'sneck. In one embodiment, body 12 has a memory shape property having aninwardly-directed bias at end portions 16. Body 12 comprises aneck-engaging inner surface 18 and an outer surface 20 opposite to theinner surface 18. Body 12 has a longitudinal axis 21 (see, FIG. 3) andwraps at least partially about the wearer's neck.

Collar 10 (and body 12) includes an opening 14 that forms adiscontinuity or gap in the collar 10 such that it does not extendaround the entirety of the circumference of the wearer's neck. This mayhelp for donning the collar 12 and/or comfort. The body 12 includes endportions 16 ₁, 16 ₂ that define the opening 14. In this example, theopening 14 of the body 12 is located in a front of the wearer's neckwhen the collar 10 is worn. More particularly, in this embodiment, theopening 14 of the collar 10 is disposed to overlie a laryngealprominence 15 of the wearer's neck. The opening 14 of the collar 10 maybe located elsewhere about the wearer's neck (e.g., on a side or a backof the wearer's neck) in other examples.

For example, in this embodiment, the collar 12 comprises a band 22configured to deform (i.e., change in shape) when the collar 12 isdonned by the wearer and to cause the collar 12 to apply the pressure onthe veins of the wearer's neck when the collar 12 is worn on thewearer's neck. For instance, in this case, the band 22 allows theopening 14 of the collar 12 to be enlarged when the collar 12 is donnedby moving the end portions 16 ₁, 16 ₂ of the collar 12 away from oneanother and then causes the opening 14 of the collar 12 to be reduced bymoving the end portions 16 ₁, 16 ₂ of the collar 12 back towards oneanother, thereby causing the collar 12 to apply the pressure on theveins of the wearer's neck.

In some embodiments, body 12 comprises band 22 is resilient to change inshape when the collar 10 is donned by the wearer by moving the endportions 16 ₁, 16 ₂ of the collar 10 away from one another and to biasthe end portions 16 ₁, 16 ₂ of the collar 10 back towards one anotherfor causing the collar 10 to apply the pressure on the veins of thewearer's neck when the collar 10 is worn on the wearer's neck. Band 22may comprises a C- or U-shaped spring or a resilient arcuate band andmay be formed from a polymeric material, a metallic material, acomposite material, or any other suitable material that allows the band22 to resiliently change in shape when the collar 10 is donned by thewearer and to cause the collar 10 to apply the pressure on the veins ofthe wearer's neck when the collar 12 is worn on the wearer's neck.

Body 12 further comprises a plurality of compressors 32 ₁, 32 ₂configured to apply the pressure on the veins of the wearer's neck. Thecompressors 32 ₁, 32 ₂ are arranged such that the collar 10 presses moreon the wearer's neck where the compressors 32 ₁, 32 ₂ are located thanelsewhere. This allows a pressure applied by the collar 10 on a regionof the wearer's neck where the veins are located to be greater than apressure applied by the collar 10 in another region of the wearer's neckwhich is engaged by the collar 10 away from the veins (e.g., the back ofthe wearer's neck). Thus, this may allow the collar 12 to optimallypress on the wearer's neck for mitigation against TBI while maintainingcomfort.

The compressors 32 ₁, 32 ₂ may be implemented in any suitable way. Forexample, in this embodiment, the compressors 32 ₁, 32 ₂ respectivelycomprise compressing protuberances 36 ₁, 36 ₂ that project inwardlytowards the wearer's neck when the collar 12 is worn. The compressingprotuberances 36 ₁, 36 ₂ are therefore such that the neck-engaging innersurface 18 of the collar 12 presses more against the wearer's neck wherethe compressing protuberances 36 ₁, 36 ₂ are located than elsewhere. Inthis example, the compressing protuberances 36 ₁, 36 ₂ are formed byenlargements of the body 12 where it is to press against the veins ofthe wearer's necks. More particularly, in this example, the enlargementsforming the compressing protuberances 36 ₁, 36 ₂ are made by wideningthe band 22 where the collar 12 is to press against the veins of thewearer's necks.

The collar 10 may be constructed in any other suitable way in otherembodiments to apply the pressure on the veins of the wearer's neck toeffectively provide protection against TBI. For example, in someembodiments, body 12 may be inflatable (e.g., the compressors 32 ₁, 32 ₂and/or another part of the body 12 may be inflatable by air or anothergas, such as by comprising an inflatable bladder and a valve).

It is understood that there is variability between individuals withrespect to neck size/diameter. For example, adults generally have alarger neck diameter than children, and men often have a larger neckdiameter than women, although there is significant overlap betweenvirtually any demographic groups that one compares, and there issignificant inter-individual variability even within demographic groups.Thus, it is desirable to provide collar device that are adjustable. Inparticular, it is desirable to provide collars and collar systems inwhich the collar diameter can be varies and/or the relative placement ofthe compressors can be altered for any given collar diameter.

As described in more detail below, adjustments to the collar 10 and/orbody 12 may include:

-   -   A length L of the body 12. In this embodiment where the body 12        is a partial collar, the length L of the body 12 is defined        between ends 17 ₁, 17 ₂ of the body 12;    -   An internal dimension D of the body 12 taken between opposite        sides 19 ₁, 19 ₂ of the neck-engaging inner surface 18 of the        body 12;    -   A dimension G of the opening 14 of the body 12;    -   Positions of the compressors 32 ₁, 32 ₂ on the body 12, such as        along the longitudinal axis 21 of the body 12;    -   Dimensions of the compressors 32 ₁, 32 ₂, such as a dimension C₁        (e.g., thickness) of each compressor 32 normal to the        longitudinal axis 21 of the body 12 and/or a dimension C₂ (e.g.,        length) of the compressor 32 along the longitudinal axis 21 of        the body 12;    -   An internal pressure of a gas (e.g., air) within the body 12        (e.g., within an inflatable member of the body 12) in        embodiments where the body 12 is inflatable; and/or    -   Any other setting of the body 12 that affects the pressure it        applies and/or where it applies the pressure on the wearer's        neck.

Adjustable Collar Bodies

FIGS. 4-6 illustrate some embodiments of adjustable collar bodies 12 inwhich the diameter D and/or length L of the body 12, and therefore thecollar 10, may be altered. Specifically, in some embodiments, theinvention provides a collar body system having a first side member 42 i,a second side member 42 k, and a central member 42 j. Each of the firstside members 42 i and second side members 42 k have a compressor 32located on the inner-facing surface 18 toward or at the end portions 16₁, 16 ₂. Typically, the first side members 42 i and second side members42 k have and equal length but opposite orientation to serve as aleft-side member and a right-side member. The collar body 12 is formedby permanently or reversible engaging the first side members 42 i with afirst end of the central member 42 j at joint 41 a, and permanently orreversible engaging the second side members 42 k with a second end ofthe central member 42 j at joint 41 b, such that a complete body 12 isformed with the compressors 32 located on the inner facing surface 18toward or at the end portions 16 ₁, 16 ₂. The combination of the firstand second side members with the central member form the collar body 12.

The invention also provides collar systems which may contain a pluralityof central members 42 j and/or a plurality of matched pairs of first andsecond side members 42 i, 42 k. In some embodiments, the system containsa single central member 42 j and a plurality of matched pairs of firstand second side members 42 i, 42 k (e.g., two, three, four, or morematched pairs). In other embodiments, the system contains a plurality ofcentral members 42 j with one or more matched pairs of first and secondside members 42 i, 42 k (e.g., one, two, three, four, or more matchedpairs). In system embodiments for which a plurality of matched pairs offirst and second side members 42 i, 42 k are provided, the various sidemember pairs may differ from each other in side length (i.e., lengthfrom joint 41 to the terminus of the end portion 16 and/or the curvatureof the side members. For example, a system may provide three matchedside member pairs characterized as having a short, medium, and longlength. Alternatively or in addition to variations in side memberlength, the curvature of side members may be varies among the pairs inorder to accommodate differently-shaped necks. For example, one sidemember pair may be nearly straight with other side member pairs defininga larger arc over the same or different length. In system embodimentsfor which a plurality of central members 42 j are provided, the centralmembers may vary from each other in length and/or curvature. Suchsystems allow the user to customize the fit of the collar device byselecting the central member and/or side member pair that most closelyapproximates the neck circumference and results in the most accurateplacement of the compressors 32 on the target neck veins.

FIGS. 4 and 5 illustrate two embodiments of these collar bodies andsystems. FIG. 4 illustrates an assembled modular collar body 12 thatuses a relatively long central member 42 j, resulting in a relativelynarrow opening 14 and smaller diameter D. In contrast, FIG. 5illustrates an assembled modular collar body 12 that uses a relativelyshort central member 42 j, resulting in a relatively larger opening 14and larger diameter D.

Joints 41 may be any suitable reversible or irreversible joining/lockingmechanism that securely fastens the side members to the central memberand retains the assembled device in a rigid form that maintains thespring-like property of the body that causes an inwardly-directed forceon the compressors 32. For example and as shown in FIG. 6, the connector46 at each end of the central member 42 j comprises a male pair member(e.g., a projection) and each end of the side members 42 i and 42 kcomprises a female pair member (e.g., a hollow space such as a recess oran opening) engageable with a complementary male part. It is understoodthat these pair members may be reversed on either or both sides of thecentral member 42 j without affecting the overall structure or assemblyof the resulting modular body 12.

FIG. 7 illustrates an alternate fastening mechanism suitable for use inthese embodiments. In this embodiment each of the central member 42 jand the individual side members 42 i and 42 k contain a complimentarynotch that engages with the other to form a unitary structure. Thenotches may be held in place using a fastener 39 such as a screw, clip,or pin. FIG. 8 illustrates an alternate configuration of this matingsystem in which the central member 42 j is fastened to the side members42 i and 42 k using magnetic connectors 43 and 46 having an oppositepolarity.

In some embodiments, the adjustable collar body 12 is provided as aunitary device in which the side members 42 i and 42 k are slidablyengaged with the central member 42 j. FIG. 9 illustrates such anadjustable collar body 12 in which the side members 42 i and 42 k aredisposed in a forward position relative to the central member 42 j,thereby increasing the diameter D of the collar body 12. FIGS. 10-12illustrate one slidable engagement mechanism in which central member 42j provides a channel 60 and receiver slot 65 into which sliding tab 62from the side member engages. Sliding tab 62 comprises stopper 63 thatprevents disengagement of side member from central member 42 j andlimits the maximum extension of that side member. The side members maybe held in a fixed position relative to the central member 42 j by anyconvenient mechanism. For example, the sides may be held in place by asimple frictional engagement between the channel 60 and the tab 62.Alternatively, as illustrated in FIG. 13, the side members may besecured by detents 74 and a series of notches 76. FIG. 13 illustrates aconfiguration in which notches 76 are present on sliding tab 62 whichengage with a single detent 74 on central member 42 j. Detent 74 extendsfrom side member 66 that is attached to central member 42 j at pivot 68.Side member 66 may be accessible to the user when the collar 10 is notworn in order to manually release detent 74 from notch 76. In oneembodiment, detent 74 may allow unidirectional movement from notch tonotch in order to facilitate proper fit after collar 10 is donned. Inthis embodiment, detent 74 may be used as the stopper by fashioning anotch 76 in a manner that prevents further extension of the side member.It is understood that this system of detents and notches may be reversedsuch that the detent(s) is/are present on the side member and thenotches present on the central member 42 j. Other fasting mechanisms areknown to those of skill in the art including, for example a friction orthumbwheel screw that can either engage with a receiver or merely act toclamp together the individual components.

Adjustable Compressors

In some embodiments, the invention also provides collars 10 that haveadjustable compressors 32 on the collar 10 or the collar body 12. FIG.14 illustrates one embodiment in which compressors 32 ₁ and 32 ₂ areslidably engaged with body 12 such that the compressors may be disposedat a plurality of locations along the inner surface of the collar 10and/or body 12 in a direction substantially parallel to the longitudinalaxis. In some embodiments, compressors 32 are slidably engaged on aslide rail 80. FIGS. 15 and 16 illustrate one example of an engagementmechanism between the slidable compressors 32 and the collar body 12.FIG. 15 illustrates a slide rail 80 that may be mounted along thelongitudinal axis of collar body 12. Slide rail 80 has a longitudinalslot 88 and a plurality of openings 90 that are contiguous with slot 88.Optionally, each opening 90 is defined by a reduced-size neck 92 and abody portion. Each opening 90 corresponds to a discrete position thatcan accept compressor 32 and is capable of securely fixing compressor 32to collar body 12.

FIG. 16 illustrates compressor 32 that may be engaged with slide rail 80illustrated in FIG. 15. Compressor 32 comprises a slidable engagementmember 84 on its outward facing side. Engagement member 84 has a headportion 86 and a neck portion 94 that has a larger diameter than neckportion 94.

FIG. 17 illustrates a cross-sectional view of engagement member 84engaged with slide rail 80. Specifically, neck portion 94 is adapted toslide freely along slot 88 and through neck 92 to engage head portion 86within the body portion of opening 90, thereby locking compressor 32into place. In one embodiment, engagement member 84 comprises anelastomeric material (e.g., rubber). The use of an elastomeric materialfor the sliding member 84 may allow the sliding member 84 to be easilysecured to the openings 90, and provide resiliency such that purposefulamount of effort is required to disengage the sliding member 84. Thesliding member 84 may be made of any other suitable material in otherembodiments.

FIG. 18 illustrates an alternate engagement mechanism for adjustablecompressors 32. In this embodiment, compressor 32 has a connector 98 onits outward-facing surface. Connector 98 may be configured to have, forexample, a neck portion and a larger head portion 106. Body 12 iscontains a plurality of cavities 96 configured to receive head portion106. Cavities 96 may have a keyhole configuration with an enlargedportion 102, adapted to receive head portion 106, and a narrow portion104, or neck, adapted to receive the neck portion of connector 98. Insome embodiments, the portion of body 12 containing cavities 96 isconstructed of sufficiently resilient material (e.g., an elastomericmaterial) to yield in order to accept head portion 106 under theapplication of a perpendicular force, hold connector 98 relativelyimmobile once in place, and resist releasing connector 98 under alateral force (i.e., approximately parallel to the longitudinal axis ofcollar 10). Optionally, the collar system provides a plurality ofmatched compressor 32 pairs having different thicknesses (heights)and/or shapes. The user can select a compressor 32 pair having theappropriate thickness and/or shape in order to customize and optimizefit and neck vein pressure.

In other embodiments, the invention provides a collar 10 and/or collarbody 12 having compressors 32 that are adjustable in a directionperpendicular to the longitudinal axis of the collar. This form ofadjustment allows the user to vary the amount of neck vein pressureapplied by compressors 32. FIGS. 19-20 illustrate one embodiment inwhich compressor 32 is mounted on an expandable element 108 that isattached to body 12. Expandable element 108 is adapted to reversiblyadjust the height of compressor 32 from height X1 (FIG. 19) to height X2(FIG. 20). In some embodiments, the compressor 32 height may beregulated by a mechanical scissor lift positioned between the compressorbody 32 and the collar body 12. The scissor lift may be a friction jointthat requires the application of more force to open/close(extend/retract) than the desired force to be applied against the neck.Modulation of the force requirement to operate the scissor lift also mayserve as a pressure limiter such that the scissor lift retracts under aforce that would apply excessive neck vein pressure. In otherembodiments, the compressor 32 height may be controlled by an inflatableelement placed between the compressor body 32 and the collar body 12.Optionally, the inflatable element also contains a pressure releasevalve which may be set to release the inflation gas at pressures thatwould apply excessive neck vein pressure to the subject.

In other embodiments, the compressor height may be adjusted using ascrew mechanism. For example, the compressor may have a threaded screwor rod extending from the outward-facing surface and the one or morecavities 96 may be threaded to accept the compressor screw. Foradjustment, the appropriate cavity 96 is selected to position thecompressor 32 in the correct longitudinal position along thelongitudinal axis of body 12. Compressor height is then adjusted by thedepth to which the compressor is screwed into selected cavity 96.

In other embodiments, the compressor height may be passively adjusted byplacing a spring between the compressor 32 and body 12. The neck veinpressure may be controlled by selection of a spring with the appropriatecompressive resiliency.

Collar with Fit Adjuster

The invention also provides collars having a fit adjustment element thatmay be used with modular and adjustable collars or unitary collars. FIG.21 illustrates a unitary collar body 12 having a fit adjustment element64 disposed on the body-facing surface. Optionally, the fit adjustmentelement 64 is positioned toward the back (dorsal) region of body 12. Thepurpose of the fit adjustment element 64 is to improve collar 10 fit ondifferently-sized necks. For example, a collar 10 may be fitted to auser such that compressors 32 are well-positioned to contact and applypressure to the neck veins but the collar may be a fractional size toolarge, thereby leaving a gap between the back of the neck and thecollar. The fit adjustment element 64 may be used to fill this gapand/or generally provide a more secure fit for the collar when wornaround the neck. In another embodiment, the invention provides a modularcollar body 12 having a fit adjustment element 64 on the central member42 j.

In one embodiment, the fit adjustment element 64 is removable.Optionally, the invention provides a system having a plurality of fitadjustment elements 64 of different sizes such that the user can selectthe most appropriate size to maximize comfort, fit, and properpositioning of the compressors. In another embodiment, the fitadjustment element 64 is inflatable.

Bend Angle Measuring System

The invention also provides systems and methods for measuring orinferring the amount of pressure applied by collar 10 to the neck veinsusing a bend angle measuring system. As described above, collar 10,including body 12, is constructed to have an inwardly directed bias whenthe collar 10 is worn such that compressors 32 apply pressure to theneck veins. The pressure applied by compressors 32 can be measured forany particular value of opening 14 and is a function of the specificmaterials and construction of collar 10. For any collar 10, the amountof pressure applied by compressors also is a function of the bend angleof collar 10 when it is worn. Thus, the compressor pressure can beinferred from the bend angle of the collar at various locations.Accordingly, the invention provides a unitary or modular collar 10having one or more bend angle sensors. FIG. 22 illustrates a collar 10having a bend angle sensor 942 positioned on the outwardly-facing sideof collar 10, in the middle of the longitudinal collar axis thatnormally would be positioned directly over the wearer's spine.Optionally, and as illustrated in FIG. 22, collar 10 further comprises abend angle sensor 942 at each of the end portions 16. For embodiments inwhich only a single centrally-located bend angle sensor is present, thecompressor pressure may be calculated from the bend angle made by thecollar in that region. For embodiments in which a plurality (e.g., twoor three) bend angle sensor are present, the compressor pressure may becalculated as a function of all measured bend angles. Optionally, collar10 further comprises a microprocessor and digital memory storage systemto measure and record the bend angles and/or compressor pressures. Thesedata may be transmitted in delayed or real-time by an optional radiotransmitter. FIG. 22 also illustrates the configuration of collar 10 inits resting configuration (solid line) and a stretched configuration asit may be when worn (dashed line), wherein the end portions 16 areoutwardly deflected by a distance “x”.

A variety of suitable bend angle sensors are known in the art. Forexample, FIG. 23 is a schematic of a capacitive bend angle sensor suchas those described in U.S. Pat. No. 5,610,528. The capacitive sensorsinclude at least two elements 11, 13 that consist of a flexible,electrically insulating material such as plastic. One surface of eachelement has a comb pattern 71, 17 of conducting material, such as ametal film or conducting polymer, and a dielectric layer, 21 coveringthe comb material. FIG. 24 illustrates the assembled bend angle sensorin which the two elements 11,13 are placed together such that the twocomb patterns 71,17 are in close proximity, separated only by one ormore dielectric layers. The two elements 11, 13 are then bondedtogether. Preferably, the comb patterns 71, 17 of each of the elements11, 13 are disposed near one end of the elements, and the elements arebonded together on the opposite end as shown in FIG. 25. Electricalcontacts 23, 25 (wires) are affixed to the conducting comb patterns 71,17. The two elements 11,13 may be placed in flexible plastic tubing (notshown) or other structure that contains and protects the two elements11,13, and keeps them pressed together.

For purposes of clarity and conciseness of the description, not all ofthe numerous components shown in the schematic are described. Thenumerous components are shown in the drawings to provide a person ofordinary skill in the art a thorough enabling disclosure of the presentinvention. The operation of many of the components would be understoodto one skilled in the art.

Each of the additional features and teachings disclosed herein can beutilized separately or in conjunction with other features and teachingsto provide the present invention. Representative examples utilizing manyof these additional features and teachings, both separately and incombination, are described in further detail with reference to theattached drawings. This detailed description is merely intended to teacha person of skill in the art further details for practicing preferredaspects of the present teachings and is not intended to limit the scopeof the claims. Therefore, combinations of features disclosed in thedetailed description may not be necessary to practice the teachings inthe broadest sense and are instead taught merely to describeparticularly representative examples of the present teachings.

Moreover, the various features of the representative examples and thedependent claims may be combined in ways that are not specifically andexplicitly enumerated in order to provide additional useful embodimentsof the present teachings. In addition, all features disclosed in thedescription and/or the claims are intended to be disclosed separatelyand independently from each other for the purpose of originaldisclosure, as well as for the purpose of restricting the claimedsubject matter independent of the compositions of the features in theembodiments and/or the claims. All value ranges or indications of groupsof entities disclose every possible intermediate value or intermediateentity for the purpose of original disclosure, as well as for thepurpose of restricting the claimed subject matter. The dimensions andthe shapes of the components shown in the figures are designed to helpunderstand how the present teachings are practiced but are not intendedto limit the dimensions and the shapes shown in the examples.

What is claimed is:
 1. A modular collar system for constructing a collarsized to be worn around the neck of a human subject, the systemcomprising: a central member having a first mating pair member at afirst end and a second mating pair member at a second end; a first sidemember having a complimentary first mating pair member at a first endand a first compressor at a second end; and a second side member havinga complimentary second mating pair member at a first end and a secondcompressor at a second end; wherein a collar defining an arc of greaterthan 180° is formed by mating the first mating pair member of thecentral member with the complimentary first mating pair member of thefirst side member and mating the second mating pair member of thecentral member with the complimentary second mating pair member of thesecond side member, wherein the second end of the first side member andthe second end of the second side member are free ends having a gaptherebetween such that the constructed collar does not extend around anentirety of the circumference of the neck, wherein the first and secondcompressors are positioned on the collar to contact two or more neckveins of the human subject when the collar is worn around the neck,wherein the collar is adapted to exert an inwardly-directed force on thefirst and second compressors when worn, and wherein the first and secondcompressors are slidably engaged with the first and second side members,respectively.
 2. The system of claim 1, wherein the first mating pairmember and the complimentary first mating pair member form a reversibleattachment and/or the second mating pair member and the complimentarysecond mating pair member form a reversible attachment.
 3. The system ofclaim 1, wherein the first and second compressors are expandable in adirection facing the neck when worn.
 4. The system of claim 1, whereinthe central member further comprises a fit adjustment element attachedto a surface facing the neck when worn.
 5. The system of claim 4,wherein the fit adjustment element is inflatable.
 6. The system of claim1, wherein the system comprises two or more central members.
 7. Thesystem of claim 1, wherein the first and second compressors arereversibly attachable to the first and second side members,respectively.
 8. The system of claim 1, further comprising a bend anglesensor configured and positioned to detect a bend angle of the collar.9. An expandable collar sized to be worn around the neck of a humansubject, the collar comprising: a central member having a first end anda second end; a first side member having a first end slidably engagedwith the first end of the central member and a second end comprising afirst compressor; and a second side member having a first end slidablyengaged with the second end of the central member and a second endcomprising a second compressor; wherein the central, first side, andsecond side members define an arc of less than 360° and greater than180° having a diameter; wherein the second end of the first side memberand the second end of the second side member are free ends having a gaptherebetween such that the constructed collar does not extend around anentirety of the circumference of the neck; wherein the diameter isaltered by the slidable engagement of the first side member and thecentral member and/or by the slidable engagement of the second sidemember and the central member; and wherein the collar is adapted toexert an inwardly-directed force on the first and second compressorswhen worn.
 10. The expandable collar of claim 9, wherein the first andsecond compressors are slidably engaged with the first and second sidemembers, respectively.
 11. The expandable collar of claim 9, wherein thefirst and second compressors are removably attached to the first andsecond side members, respectively.
 12. The expandable collar of claim 9,wherein the first and second compressors are expandable in the adirection facing the neck when worn.
 13. The expandable collar of claim9, wherein the central member further comprises a fit adjustment elementattached to a surface facing the neck when worn.
 14. The modular collarof claim 13, wherein the fit adjustment element is inflatable.
 15. Theexpandable collar of claim 9, further comprising a bend angle sensorconfigured and positioned to detect a bend angle of the collar.
 16. Acollar sized to be worn around the neck of a human subject, the collarcomprising: a central member having a first end and a second end; afirst side member having a first end engaged with the first end of thecentral member and a second end comprising a first compressor; and asecond side member having a first end engaged with the second end of thecentral member and a second end comprising a second compressor; whereinthe central, first side, and second side members define an arc of lessthan 360° and greater than 180° having a diameter that is alterable;wherein the second end of the first side member and the second end ofthe second side member are free ends having a gap therebetween such thatthe constructed collar does not extend around an entirety of thecircumference of the neck; wherein the first and second compressors aremovably engaged with the first and second side members, respectively;and wherein the collar is adapted to exert an inwardly-directed force onthe first and second compressors when worn.
 17. The collar of claim 16,wherein the first and second compressors are slidably engaged with thefirst and second side members, respectively.
 18. The collar of claim 16,wherein the first end of the first side member has a first releasableengagement with the first end of the central member and the first end ofthe second side member has a second releasable engagement with thesecond end of the central member, and wherein the diameter is alterableby replacing one or more of the first side member, the second sidemember, and the central member at the first or second releasableengagements.
 19. The collar of claim 16, wherein the first end of thefirst side member has a first slidable engagement with the first end ofthe central member, and wherein the diameter is altered by the firstslidable engagement of the first side member and the central member. 20.The collar of claim 19, wherein the first end of the second side memberhas a second slidable engagement with the first end of the centralmember, and wherein the diameter is altered by the second slidableengagement of the second side member and the central member.
 21. Thecollar of claim 16, wherein the first end of the second side member hasa second slidable engagement with the first end of the central member,and wherein the diameter is altered by the second slidable engagement ofthe second side member and the central member.
 22. The collar of claim16, further comprising a bend angle sensor configured and positioned todetect a bend angle of the collar.